VISEN Announces Acceptance of a BLA for Lonapegsomatropin in China
SHANGHAI, Jan. 6, 2023 /PRNewswire/ -- VISEN Pharmaceuticals, an innovative biopharmaceutical company focused on endocrine diseases, announced today that it has completed the double-blind period of PaTHway China Trial, a phase 3 China clinical trial for its innovative investigational new prodrug palopegteriparatide on January 4, 2023, and it would start to carry out analysis of the primary endpoints. Palopegteriparatide is designed to restore parathyroid hormone (PTH [1-34]) to physiological levels over 24 hours in adult patients with hypoparathyroidism (HP).
SHANGHAI, Nov. 17, 2022 /PRNewswire/ -- VISEN Pharmaceuticals, an innovative biopharmaceutical company focused on endocrine diseases, today released for the first time detailed clinical data from its pivotal Phase 3 study of lonapegsomatropin, a long-acting prodrug of unmodified somatropin being investigated as a once-weekly injection in children with growth hormone deficiency (GHD) in China.
-  VISEN’s Phase 3 Trial achieved primary endpoint; pediatric growth hormone deficiency (GHD) patients treated with TransCon™ hGH demonstrated greater annualized height velocity at 52-weeks...
SHANGHAI, May 23, 2022 /PRNewswire/ -- VISEN Pharmaceuticals, an innovative biopharmaceutical company focused on endocrine diseases, today announced positive top-line results from its pivotal phase 3 trial, a randomized, open-label, active-controlled trial that compared lonapegsomatropin (TransCon hGH), a once-weekly administered long-acting drug that delivers unmodified growth hormone, to a daily human growth hormone (hGH) in children with growth hormone deficiency (GHD) in China.
1. VISEN Pharmaceuticals has obtained the investigational new drug (IND) approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the phase III China clinical trial (PaTHway China Trial) of TransCon PTH Solution for Injection (TransCon™ parathyroid hormone).